(119 days)
The PTFE Peelable Introducer is intended for use in the percutaneous insertion of pacing leads or catheters in the venous system.
The Enpath Medical PTFE Peelable Introducer kit consists of a disposable needle, a disposable syringe, a guidewire, and a peelable introducer set consisting of a dilator and sheath with integrated proximal handles. The Introducer is available in various lengths in 3.5F through 7F (micro) and 7F through 16.5F (macro). The dilator is designed to be delivered over a 0.018" guidewire (micro) up to a 0.038" guidewire (macro). The dilator and hub is constructed of high density polyethylene. The outer sheath and handle is constructed of PTFE and TPX. The inner dilator and outer sheath are radiopaque so that they are visible under fluoroscopy. The hub of the dilator has a spin lock design that connects to the luer of the sheath when rotated. The Percutaneous Introducer sheath has a "tear-away" feature which allows the user to remove the sheath without removing the inserted catheter or pacing lead. The kit is packaged in a tray and placed into a poly-Tyvek pouch and sealed.
Here's an analysis of the provided text regarding the acceptance criteria and study for the PTFE Peelable Introducer:
This document is a 510(k) summary for a medical device seeking substantial equivalence to a predicate device. It focuses on non-clinical testing for equivalence rather than establishing new clinical effectiveness or performance criteria for a novel device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Device functions in a safe and effective manner | Test results verify that the device performs per specification requirements and is equivalent to the predicate device. |
| Device performs per specification requirements | Test results confirm the device performs as intended. |
| Device is equivalent to the predicate device without creating additional risk to the patient or user | Substantially equivalent to the currently marketed Enpath Medical Percutaneous Introducers based on a comparison of the indications for use and the technological characteristics. |
| Functional and dimensional testing of the PTFE Peelable Introducer meets requirements | Performance testing included functional and dimensional testing. (Specific criteria not detailed, but states it met them). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The document states "Performance Testing: The performance testing for this device included testing to verify that the device continues to functions in a safe and effective manner." This implies a physical testing or engineering study, not a clinical trial with human subjects.
- Data Provenance: The testing was "non-clinical." This means it was likely laboratory or bench testing performed by the manufacturer, Enpath Medical, probably in the US where the company is based. It is retrospective in the sense that it's based on internal validation against predefined specifications rather than a prospective trial with patient enrollment.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. As this was non-clinical performance testing, there was no "ground truth" to be established by clinical experts in the traditional sense. The "ground truth" was likely the engineering specifications and performance characteristics of the predicate device.
4. Adjudication Method for the Test Set
- Not Applicable. There was no human reading or interpretation of results that would require an adjudication method. The testing involved objective measurements against specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. The document explicitly states: "Summary of Clinical Testing: No clinical evaluations of this product have been performed." Therefore, no MRMC study was conducted.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Not Applicable. This is a physical medical device (an introducer kit), not an AI algorithm or software. Therefore, the concept of "standalone performance" for an algorithm does not apply. The performance assessed was the physical device itself.
7. Type of Ground Truth Used
- Engineering Specifications / Predicate Device Characteristics. For the non-clinical testing, the ground truth was the established engineering specifications for the device and the performance characteristics of the predicate device (Enpath Medical, Inc. Percutaneous Introducer K000824). The goal was to show the new device met its own specifications and performed equivalently to the predicate.
8. Sample Size for the Training Set
- Not Applicable. There was no "training set" as this device is not an AI/ML algorithm. The testing involved physical device samples.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there was no training set, this question is irrelevant. The "ground truth" for the non-clinical testing (not training) was based on established engineering standards and comparison to a legally marketed predicate device.
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SEP 1 5 2008
510(K) Summary
510(k) Number: K081394
Date Prepared
August 19, 2008
Submitter Information
Submitter's Name/ Address:
Enpath Medical 2300 Berkshire Lane North Minneapolis, MN 55441
Establishment Registration: 2183787
Contact Person:
Shannon Springer Principal Regulatory Affairs Associate sspringer@enpathmed.com (763) 951-8244 (phone) (763) 559-0148 (fax)
Device Information
Trade Name: Classification Name: Product Code: Regulation: Panel:
PTFE Peelable Introducer Introducer, Catheter DYB Class II, 21 CFR 870.1340 Cardiovascular
Performance Standards
No performance standards applicable to this product have been developed under Section 514 of the Act.
Predicate Device
Enpath Medical, Inc. Percutaneous Introducer (K000824)
Device Description
The Enpath Medical PTFE Peelable Introducer kit consists of a disposable needle, a disposable syringe, a guidewire, and a peelable introducer set consisting of a dilator and sheath with integrated proximal handles. The Introducer is available in various lengths in 3.5F through 7F (micro) and 7F through 16.5F (macro). The
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dilator is designed to be delivered over a 0.018" guidewire (micro) up to a 0.038" guidewire (macro).
The dilator and hub is constructed of high density polyethylene. The outer sheath and handle is constructed of PTFE and TPX. The inner dilator and outer sheath are radiopaque so that they are visible under fluoroscopy. The hub of the dilator has a spin lock design that connects to the luer of the sheath when rotated.
The Percutaneous Introducer sheath has a "tear-away" feature which allows the user to remove the sheath without removing the inserted catheter or pacing lead. The kit is packaged in a tray and placed into a poly-Tyvek pouch and sealed.
Indications for Use
Peclable Introducer is intended for use in the percutaneous insertion of pacing leads or catheters in the venous system.
Summary of Non-Clinical Testing
Performance Testing: The performance testing for this device included testing to verify that the device continues to functions in a safe and effective manner. The performance testing included the device specifications, functional and dimensional testing of the PTFE Peelable Introducer and other testing as applicable to the device. Test results verify that the device performs per specification requirements and is equivalent to the predicate device without creating additional risk to the patient or user.
Summary of Clinical Testing
No clinical evaluations of this product have been performed.
Statement of Equivalence
Through the data and information presented. Enpath Medical considers the PTFE Peelable Introducer to be remain substantially equivalent to the currently marketed Enpath Medical Percutaneous Introducers based on a comparison of the indications for use and the technological characteristics. The testing performed confirms that the PTFF. Peelable Introducer will perform as intended.
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Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" are arranged in a circular pattern around the eagle. The logo is black and white.
SEP 1 5 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Enpath Medical, Inc. c/o Ms. Shannon Springer Principal Regulatory Affairs Associate 2300 Berkshire Lane North Minneapolis, MN 55441
Re: K081394
Trade/Device Name: PTFE Peelable Introducer Regulation Number: 21 CFR 870.1340 · Regulation Name: Introducer, Catheter Regulatory Class: Class II Product Code: DYB Dated: August 19, 2008 Received: August 20, 2008
Dear Ms. Springer:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality
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Page 2 - Ms. Shannon Springer
systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Damen D. Kirchner
Image /page/3/Picture/5 description: The image contains a handwritten-style symbol or signature on the left, resembling a stylized letter or abstract design. To the right of this symbol are the capital letters 'E' and 'R' stacked vertically, suggesting they might be initials or part of a larger word. The overall impression is that of a signature or mark, possibly from a document or piece of artwork.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known): K081394
Device Name: PTFE Peelable Introducer
Indications for Use:
The PTFE Peelable Introducer is intended for use in the percutaneous insertion of pacing leads or catheters in the venous system.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
ﺮ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ munder
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_K081394
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).